Druggability

To offer comprehensive solutions to Mycenax’s customers, we provide one-stop shop services including cell line development, upstream cell culture process development, downstream purification process development, formulation development, analytical method development, process scale-up study, PIC/S GMP production and aseptic fill and finish.

Protein drugs usually have individual differences in post-translational modification, solubility, aggregation, and stability. These differences are potential risks for drug development.

A good developability assessment can identify the differences mentioned above in advance and provide the basis for further process development. Through Mycenax’s extensive experiences, we tailor a complete set of developability studies for early-stage drug development to reduce the barriers for future products to enter large-scale production and PIC/S GMP production, and improve drug safety, effectiveness, and quality. Our developability studies can shorten the drug development timeline, cost, and failure rates.

Mycenax’s developability studies include but are not limited to:   ◆    In silico analysis   ◆    Chemical stability ◆    Sequence and structural analysis   ◆    Post-translational modifications ◆    Heterogeneity   ◆    Affinity analysis ◆    Product yield and productivity   ◆    Potency analysis ◆    Propensity of aggregation     ◆    Physical stability